Varénicline-DALITA 0.5 mg
Varénicline-DALITA 0.5 mg is a medicine authorised by Swissmedic under authorisation number 70067. The authorisation holder is DALITA SA. The medicinal product code is Synthetic medicines and the dispensing category is B: Supplied only against a prescription which, at the prescriber's discretion, may be dispensed repeatedly. First authorisation was granted on 08 July 2025 and the authorisation is limited until 07 July 2030. ATC code N07BA03 places the medicine in the group Other nervous system drugs.
| Authorisation number | 70067 |
|---|---|
| Name | Varénicline-DALITA 0.5 mg |
| Full name | Varénicline-DALITA 0.5 mg, comprimés pelliculés |
| Authorisation holder | DALITA SA |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | N07BA03 |
| First authorisation | 08 July 2025 |
| Authorisation validity | 07 July 2030 |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Varénicline-DALITA 0.5 mg, comprimés pelliculés | B | 08 July 2025 |
| 2 | Varénicline-DALITA 1 mg, comprimés pelliculés | B | 08 July 2025 |
| 3 | Varénicline-DALITA 0.5 mg + 1 mg, comprimés pelliculés | B | 08 July 2025 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 56 | Tablette(n) | N07BA03 | 15.02.0. | B |
| 2 | 56 | Tablette(n) | N07BA03 | 15.02.0. | B |
| 4 | 11 + 42 | Tablette(n) | N07BA03 | 15.02.0. | B |
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Medicines in the same ATC group
Frequently asked questions
Is Varénicline-DALITA 0.5 mg authorised in Switzerland?
Yes. Varénicline-DALITA 0.5 mg is authorised by Swissmedic under authorisation number 70067, data as of 01 September 2026. The authorisation is limited until 07 July 2030.
Which dispensing category does Varénicline-DALITA 0.5 mg have?
Varénicline-DALITA 0.5 mg is in dispensing category B. Supplied only against a prescription which, at the prescriber's discretion, may be dispensed repeatedly.
Who is the authorisation holder of Varénicline-DALITA 0.5 mg?
The authorisation holder is DALITA SA. The holder carries the legal responsibility for quality, safety and product information of the medicine in Switzerland.
Sources
Swissmedic data as of 01 September 2026. No medical advice. Independent directory, not affiliated with Swissmedic or the FOPH.